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HIV TESTING: FDA Approves First Urine Test

The first urine test for detecting the HIV virus has been approved and licensed by the FDA, Calypte Biomedical Corp., the test's Berkeley-based manufacturer announced yesterday. The HIV-1 Western Blot Test confirms the presence of antibodies which the human body produces in response to HIV Type 1 in urine samples. When cross-checked with a blood-based serum test in clinical trials, the sensitivity of the urine-based test was 99.7%, or 746 out of 748 (release, 6/2). The Agence France-Presse/Washington Times reports that "Cambridge Biotech Corporation manufactures the new urine-based test under license from Calypte." Cambridge was previously the first manufacturer to gain FDA approval for an HIV blood test more than ten years ago. Dr. Luc Montagnier, one of the discoverers of AIDS, said, "In my opinion, the urine HIV testing system is highly reliable and readily accepted by the patients" (6/2).

Advantages The advantages of the new test include "greater ease of use and lower cost for health care providers, and a safer procedure for patients." Health care workers also would not have to worry about accidental infection as a result of needle sticks, as there is no evidence that HIV can be transmitted through urine (New York Times, 6/2). "A recent survey showed that half of respondents would prefer a urine HIV test over a blood test, most citing a fear of needles," Agence France-Presse/Washington Times reports. As some 60 million HIV tests are performed in the U.S. each year, the new test might affect a significant number of patients (6/2). The test is further expected to appeal to domestic and international health agencies that do not have access to the funds, personnel or facilities required for blood collection and testing. A December 1997 report issued by the World Health Organization and UNAIDS concluded, "Conservative estimates suggest that nine out of 10 infected people in the world do not know their HIV status. At current estimates, that would suggest there are over 27 million people in the world today that do not know they are infected." Bill Boeger, President and CEO of Calypte, said: "Many people who may be at risk for HIV infection have declined testing in the past because of the pain, cost and inconvenience of having their blood drawn. We expect that by making urine HIV-1 testing widely available, many people who have previously declined blood testing will now come forward" (release, 6/2).

Some Potential Drawbacks The Contra Costa Times reports that the "FDA approval came with some caveats: It is not approved for use as a screening tool at blood banks." The agency also cautioned that false-positive results were more likely in persons with kidney or liver disease. Confidentiality concerns were also raised, as some AIDS advocacy groups question whether patients will be notified that they are being tested for AIDS when giving a urine sample. However, Calypte said it addressed that concern by providing an informational brochure for patients that has a peel-off sticker that must be placed on the "sample cups before labs will process the tests." Mark Bowers of the Bulletin of Experimental Treatments for AIDS in San Francisco said, "If this is a way to interest more people in getting tested, we're happy to support that" (Appleby, 6/2).

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